Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome (TSMFS-FMS)

University of Seville

Status: Completed

Conditions: Fibromyalgia

Treatments: Procedure: transcranial static magnetic field stimulation (tSMS); Procedure: Sham transcranial static magnetic field stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04836325

JJJimenez-Rejano, USeville

Details and patient eligibility

About

The main objective is to know if the transcranial static magnetic field stimulation (tSMS) reduces the perception of pain in patients with fibromyalgia and its effect on health-related quality of life. In addition, it will seek to limit the parameters necessary to achieve efficiency with the technique.

Full description

Background:

Various non-invasive brain stimulation techniques have been successfully tested in fibromyalgia syndrome (FMS). Transcranial static magnetic field stimulation (tSMS) is a new, portable and inexpensive non invasive brain stimulation (NIBS) technique that has shown security, biological effects, and therapeutical effects in some pathologies. Some studies have studied its effect in pain central processing, our aim is to study its effect on FMS. The safety that tSMS has demonstrated in several clinical trials opens doors to future clinical trials that will extend its clinical utility.

Objectives:

To investigate the effect of tSMS on pain in patients with FMS, using subjective and objective assessment measures. Identify dose response to the treatment to limit the parameters required to achieve effectiveness with the technique.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Formal diagnosis of fibromyalgia syndrome (FMS).
• No change in the last 4 weeks on their standard treatment.
• They must have pain for more than 6 months (at least 4 on the VAS scale).
• Score on the fibromyalgia impact questionnaire (FIQ) greater than 39.

Exclusion criteria

• Presence of concomitant autoimmune or hematologic diseases.
• Neuropsychiatric disorders.
• Pacemakers or neurostimulators implants.
• Substance abuse or other pathologies that can explain chronic pain.
• Pregnant or lactating women.
• Those who are receiving any other type of physiotherapy treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

Experimental: transcranial static magnetic field stimulation (tSMS)

Experimental group

Description:

The intervention group will receive a treatment of Transcranial Static Magnetic Field Stimulation (tSMS) in the primary motor cortex with a duration of 30 minutes, 5 times a week, during 4 weeks, for a total of 20 sessions.

Treatment:

Procedure: transcranial static magnetic field stimulation (tSMS)

Sham transcranial static magnetic field stimulation

Sham Comparator group

Description:

The placebo group will receive a dummy treatment with a duration of 30 minutes, 5 times a week, during 4 weeks, for a total of 20 sessions.

Treatment:

Procedure: Sham transcranial static magnetic field stimulation